U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease (Johnson & Johnson)

Johnson & Johnson announced FDA approval for TREMFYA® (guselkumab) as a treatment for adults with moderately to severely active Crohn’s disease (CD), making it the first IL-23 inhibitor to offer both intravenous (IV) and subcutaneous (SC) induction options. Backed by robust Phase 3 data from GRAVITI and GALAXI studies, TREMFYA® demonstrated significant clinical and endoscopic remission rates, outperforming STELARA® across pooled endoscopic endpoints. This milestone marks TREMFYA®’s fourth U.S. indication and brings greater flexibility to patients with chronic immune-mediated diseases.